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Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)
This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center
Sponsor:
University of Colorado Denver School of Medicine Barbara Davis Center
ClinicalTrials.gov Identifier:
NCT03143816
First Posted: May 8, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation
Information provided by (Responsible Party):
Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.
Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Technosphere insulin
Phase 4
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study
Resource links provided by NLM:
Genetics Home Reference related topics: type 1 diabetes
MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin Insulin human Insulin aspart
U.S. FDA Resources
Further study details as provided by Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center:
Primary Outcome Measures:
Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]
Estimated Enrollment: 60
Anticipated Study Start Date: September 30, 2017
Estimated Study Completion Date: October 15, 2017
Estimated Primary Completion Date:
clinicaltrials.gov/ct2/show/NCT03143816
We will be updating this site in phases. This allows us to move faster and to deliver better services. Show less
ClinicalTrials.gov
ClinicalTrials.gov Menu
HomeStudy Record DetailSaved Studies (0) Save this study
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)
This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center
Sponsor:
University of Colorado Denver School of Medicine Barbara Davis Center
ClinicalTrials.gov Identifier:
NCT03143816
First Posted: May 8, 2017
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation
Information provided by (Responsible Party):
Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.
Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Technosphere insulin
Phase 4
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study
Resource links provided by NLM:
Genetics Home Reference related topics: type 1 diabetes
MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin Insulin human Insulin aspart
U.S. FDA Resources
Further study details as provided by Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center:
Primary Outcome Measures:
Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]
Estimated Enrollment: 60
Anticipated Study Start Date: September 30, 2017
Estimated Study Completion Date: October 15, 2017
Estimated Primary Completion Date:
clinicaltrials.gov/ct2/show/NCT03143816